HCPLive 5 Stories in Under 5: Week of 12/28

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for December 28-January 3, 2025:

1. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care

The FDA granted 510(k) clearance to StimLabs’ Theracor, marking the first umbilical cord–derived wound care device available in a sheet formulation.

2. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion

The FDA approved tradipitant as the first new pharmacologic option in decades for preventing motion sickness–related vomiting.

3. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism

The FDA issued a CRL for relacorilant, citing the need for additional evidence of effectiveness despite positive findings from completed trials.

4. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD

The FDA again declined approval of ONS-5010 for wet AMD, reiterating that confirmatory evidence of efficacy is required to support the application.

5. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer’s Disease Agitation

The FDA accepted and granted Priority Review to the sNDA for AXS-05, advancing a potential new treatment option for agitation in Alzheimer’s disease.